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Terminated

Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

FDA Recall Z-0945-05 · Posted 2005-06-30

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLLD
Date Initiated2005-06-08
Date Terminated2007-02-15

Reason for Recall

Potential for port housing separation after implantation.

Firm Action

A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.

Root Cause

Other

Distribution Pattern

Product shipped to 56 medical facilities throughout the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032600VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233Boston Scientific Corp · 2003-09-09K032375VAXCEL PORT, MODELS 45-336 AND 45-338Boston Scientific Corp · 2003-08-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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